UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053757 |
|---|---|
| Receipt number | R000061345 |
| Scientific Title | An Exploratory Study of the Effects of Attention-Disturbing Stimuli on Short-Term Memory Function |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2024/03/01 23:54:54 |
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Basic information
Public title
An exploratory study of the effects of attention-disturbing stimuli on short-term memory function in normal-hearing subjects and patients with listening difficulties.
Acronym
An Exploratory Study of the Effects of Attention-Disturbing Stimuli on Short-Term Memory Function
Scientific Title
An Exploratory Study of the Effects of Attention-Disturbing Stimuli on Short-Term Memory Function
Scientific Title:Acronym
An exploratory study of the effects of attention-disturbing stimuli on short-term memory function in normal-hearing subjects and patients with listening difficulties.
Region
| Japan |
Condition
Condition
Listening difficulties
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of various attentional interference stimuli on Digit Span, a test of short-term memory, performance of visual Span, and speech intelligibility will be explored in normal hearing subjects and patients with listening difficulties to provide basic data for establishing a clinical test method to evaluate memory function pathology in patients with listening difficulties.
Basic objectives2
Others
Basic objectives -Others
Assessment of memory function pathology in patients with listening difficulties
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum number of digits in Digit span
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Hearing-impaired subjects (normal volunteers)
1) Normal hearing subjects with no history of ear, nerve or neurological diseases and no abnormalities in auditory function
(2) Age: 18 years old or older, less than 50 years old (at the time of registration)
(3) Gender: Any gender
(2) Listening difficulties patients (patient volunteers)
(1) Patients diagnosed with the syndrome or suspected of having the syndrome by an audiologic evaluation at an ENT clinic.
(2) Age: 18 years old or older, under 50 years old (at the time of registration) (3) Gender: Any gender
Gender: Any gender
Key exclusion criteria
(1) Healthy hearing subjects (normal volunteers)
1) Subjects with a history of ear disease
2) Subjects with a history of psychiatric disease
(3) Subjects with a history of peripheral or central nervous system disease
(4) Pregnant or possibly pregnant
(5) Other patients who are judged to be unsuitable as subjects by the principal investigator or subinvestigators.
(2) Patients with Lstening difficulties (patient volunteers)
(1) Patients with a history of peripheral or central nervous system disease
(2) Pregnant or possibly pregnant
(iii) Other patients who are judged to be inappropriate as subjects by the principal investigator or subinvestigators.
(Because the patient background for #Listening difficulties is also known to include a history of childhood ear disease, neurodevelopmental disorders, depression, and other psychiatric disorders, the conditions of a history of ear disease or psychiatric disorders that are excluded in healthy hearing subjects were not added to the exclusion criteria)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
graduate school of medicine
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
022-717-7304
kawase@orl.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
graduate school of medicine
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
022-717-7304
Homepage URL
kawase@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of test subjects begins.
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061345
